NCT03198988

Functionality and Accuracy of the smART System in Real-Life ICU Settings

• Status: Terminated
• Phase: —
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: ART Medical Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Total participants in the "Functionality and Accuracy of the smART System in Real-Life ICU Settings" are 10 participants - in the current Jefferson study site there were 8 participants and in the Sheba study site (identifier NCT03689985) there were 2 participants. This study is conducted in order to validate the functionality and accuracy of the smART™ System in a real-life ICU setting. The smART™ Feeding Tube System is a novel system with nasogastric tube developed by ART Medical (Healthcare) Ltd, based on sensor-lined tubes that transmit real-time information to an external console. The smART™ feeding tube is equipped with reflux sensors which alert when gastric contents regurgitating into the esophagus. In addition, the smART™ feeding tube is equipped with sensors designed to provide information about the location of the tube thus assisting in reducing the incident of misplacement during first positioning. The smART™ feeding tube is also automatically and in real-time stops feeding if the feeding tube moves out of position during ongoing use or detect gastric content in esophagus. Furthermore, smART™ Feeding Tube System can guide operator to correctly re-position the tube. Lastly the smART™ Feeding Tube System is equipped with an anti-reflux mechanism and automatic Gastric Residual Volume (GRV).

Conditions

• Aspiration Pneumonia

Interventions

Type	Name	Description
DEVICE	smART Feeding Tube System	Replacing generic feeding tube with smART Feeding Tube System.

Timeline

• Start date: 2017-10-26
• Primary completion: 2020-04-28
• Completion: 2020-04-28
• First posted: 2017-06-26
• Last updated: 2023-02-13
• Results posted: 2023-02-13

Locations

1 site across 1 country: United States